An increasingly widespread technique for treating female urinary incontinence is that of sling suspension. Examples of such procedures and equipment which can be employed are discussed in U.S. Pat. Nos. 5,112,344, 5,899,909, and 6,273,852, the contents of which are incorporated herein by reference.
Generally, sling suspension procedures involve the placement of a sling member beneath the patient's urethra. The sling member is preferably implanted in the patient's tissue by using an introducer needle to help draw the tissue implant sling into position.
Slings have been made from tape or mesh. Numerous implant materials have been considered and used for sling procedures, including both synthetic and natural materials.
A traditional sling procedure involves placing a strip of an implant material (natural tissue or synthetic mesh) under the urethra and securing it to the rectus fascia or other portions of the patient's anatomy with sutures to hold the implant in position during the healing process.
Recently, improved techniques have been developed that speed the implant process, by reducing the number of incisions made and altering the pathways by which the tissue implant is introduced into the body. These improvements, which employ specialized instrumentation, help to reduce operative time and have made the procedure less invasive.
These techniques generally require that an implant be joined to an introducer needle. The implant is inserted into, and pulled through the body. Then, in a subsequent step, the implant is detached from the introducer needle. A deficiency with existing introducer devices, however, is that they are typically unwieldy, awkward and time consuming to attach and/or detach to an implant to or from an introducer device.
Another deficiency with existing introducer systems is that, in performing certain procedures, such as a transobturator needle inside-out approach in which the needle is first inserted and then passed through the obturator foramen, the use of existing introducer needles is commonly not practical because once in an earlier step, the tissue implant is passed through the obturator foramen, there is typically no practical method to position both ends of a tissue implant firmly in place under the bladder, because the introducer handle is typically, at that point, oriented on the wrong side of the introducer needle at that intermediate stage in the process. In addition, various proposed needle shapes make the procedure difficult, because of problems encountered when trying to predict the path the needle will take through the body.
Existing surgical hardware, such as the McGuire™ suture guide, which has a central suturing hole, and available from C.R. Bard, Inc. of Murray Hill, N.J., is based on what is known as the “Stamey” needle. Although such devices could be modified for use in the field of this invention, they do not possess all the requisite properties for the uses envisioned for this invention.
Thus, there exists a long-felt and unsolved need for a sling suspension introducer system which offers the distinct benefits of allowing tissue implants to be quickly and efficiently attached and detached to and from an introducer needle, and which allows for practical convenient insertion of an implant.